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2026-06-02 15:43:15 +02:00
parent c480111552
commit 4cfda9d162
11 changed files with 420 additions and 141 deletions
+41 -13
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@@ -6,13 +6,15 @@ output:
toc: true
toc_depth: 3
header_includes:
-\usepackage{fancyheadr}
-\setlength{\headheight}{22pt}%
-\usepackage{lastpage}
-\pagestyle{fancy}
-\usepackage{pdflscape}
-\usepackage{longtable}
-\rhead{\includegraphics[width=.15\textwidth]{`r getwd()`/logo.png}}
-\usepackage{fancyheadr}
-\pagestyle{fancy}
-\fancyhf{}
-\fancyfoot[C]{Page \thepage \ of \pageref{LastPage}}
-\usepackage{lastpage}
-\rhead{\includegraphics[width=.15\textwidth]{`r getwd()`/logov2.png}}
params:
FileName: NA
newTitle: NA
@@ -24,7 +26,7 @@ params:
Assay: NA
author: "Author: `r params$author`"
title: |
| ![](logo.png){width=1in}
| ![](logov2.png){width=1in}
| Linear bioassay evaluation
subtitle: |
`r params$FileName`
@@ -34,10 +36,7 @@ date: "`r paste(params$NoP, params$Assay)`"
---
<!-- \fancyfoot[C]{\thepage\ of \pageref{LastPage}} -->
<!-- \newpage -->
<!-- \newpage -->
```{r setup, include=FALSE}
@@ -69,6 +68,8 @@ ANOVAlin <- LinTests[,4:ncol(LinTests)]
```
\newpage
# Introduction
Bioassay potency estimation uses statistical methods to quantify the strength of a biological product or drug by comparing its response to that of a reference standard. Biological responses are inherently variable, affected by assay conditions, cell systems or organisms, and measurement noise. To control this variability, a linear regression approach is used to obtain reliable potency values. Three consecutive dilution steps showing the steepest slope are used for linear fitting.
@@ -139,7 +140,7 @@ plot_grid(XLplotLin)
```
The relative potency can be read from tbale 3.
The relative potency can be read from tabale 3.
```{r LinPotTab, echo=FALSE, warning=FALSE, results='asis'}
@@ -148,7 +149,9 @@ kable(LinPotTab, format = "markdown", caption= "Potency table", digits=3)
```
0 ... test passed;
1 ... test failed);
The ANOVA of the unconstrained model is listed in table 4.
@@ -173,7 +176,6 @@ kable(LinTests1, row.names = F, format = "markdown", caption="Assay suitability
```
The estimate is the p-value of the test.
F-tests on regression, significance of slopes, and preparation need to have a p-value <0.05 to pass.
All other tests pass if p-value > 0.05.
@@ -209,6 +211,22 @@ kable(SuModABu, format = "markdown", caption= "Restricted linear regression (SSS
SSSI: separate slope, separate intercept
# Signature
<!-- Signature and date:\\ -->
<!-- \noindent\framebox(200,50) -->
<!-- \begin{minipage}[t][40pt][c]{190pt} -->
<!-- \centering -->
<!-- % Leave this blank for a physical signature -->
<!-- \end{minipage} -->
\vspace{1.5cm}
\noindent
\begin{tabular}{p{6cm}p{1cm}p{6cm}}
\cline{1-1} \cline{3-3}
Date & & Signature
\end{tabular}
@@ -216,12 +234,22 @@ SSSI: separate slope, separate intercept
## Potency of linear PLA
Relative potency of the test sample to the reference is calculated as:
$$
rel Potency = \frac{I_{ref} - I_{test}}{k}
relPot_{log} = \frac{I_{ref} - I_{test}}{k}
$$
where: I... intercept of reference or test
where: \\ I... intercept of reference or test\\
k ... common slope
The standard error of the linear restricted model is used to get the confidence interval of the relative potency with the formula:
$$
CI_{rel Pot} = exp(relPot_{log} \pm se(relPot_{log})*q^{t_{n-p}}_{1-\frac{\alpha}{2}})
$$
In general, the confidence intervals are calculated as follows:
$$
CI = \hat\theta\pm se(\hat\theta)*q^{t_{n-p}}_{1-\frac{\alpha}{2}}
$$
…where $\hat\theta$ is a fitted parameter or a linear combination thereof, q is the 1-alpha/2 quantile of the Students t-distribution with n-p degrees of freedom and se is the standard error derived from any covariance matrix.
# Literature